他汀类药物治疗心房颤动随机对照试验的Meta分析

目的评价他汀类药物抗心房颤动（房颤）的疗效。方法采用Cochrane系统评价的方法,计算机检索PubMed、EMbase、EMB Reviews—Cochrane Central Register of Controlled Trials（2007年第3期）、中国生物医学文献数据库、中文科技期刊数据库,中国期刊全文数据库,检索时间截至2007年9月15日,纳入中外文他汀类药物抗房颤的随机对照试验（RCTo由两名评价者独立评价纳入研究质量、提取资料并交叉核对。采用RevMan4．3软件进行Meta分析。结果共纳入5个RCT,包括470例房颤患者。各研究间存在统计学异质性（I^2=66．8％,P=0．02）,故采用随机效应模型进行合并分析,其结果显示,他汀类药物可减少房颤复发,发生率[RR=0．61,95％CI（0．43,0．88）,P=0．008o敏感性分析显示结果稳定性较好,失安全数为52．91。结论他汀类药物可以有效降低房颤的复发和发生率。但本研究中部分文献质量不高,加之有关他汀类药物预防房颤的RCT文献数量较少,总样本量较小,上述结论尚有待开展大样本、随机、双盲对照试验证实。     

Periodic Salbutamol in Facioscapulohumeral Muscular Dystrophy: A Randomized Controlled Trial

Payan CA, Hogrel JY, Hammouda EH, Lacomblez L, Ollivier G, Doppler V, Eymard B, Attarian S, Pouget J, Desnuelle C, Laforêt P. Periodic salbutamol in facioscapulohumeral muscular dystrophy: a randomized controlled trial.

Objective

To evaluate the effects on muscle strength of salbutamol administered for 6 months using a periodic regimen in patients presenting with facioscapulohumeral muscular dystrophy (FSHD).

Design

Placebo-controlled double-blind randomized study.

Setting

Three clinical centers involved in neuromuscular disorders.

Participants

Ambulatory patients (N=112), 56 per group, with genetically confirmed FSHD, age 18 to 60 years.

Interventions

Salbutamol (sustained released formulation) administered orally at a daily dose of 16mg using a periodic dosage regimen (3wks on, 1wk off).

Main Outcome Measures

Muscle strength was assessed with quantitative muscle testing (QMT), manual muscle testing (MMT), and timed motor tests. Patients were evaluated at baseline, and 3 and 6 months later. Plasma drug assays were carried out at each visit.

Results

There was no significant change with periodic use of salbutamol in the total composite QMT z-score, MMT score, or timed motor tests. Salbutamol was well tolerated. Lack of efficacy did not seem to be related to plasma concentrations, which were within the expected range.

Conclusions

Results from this study and previous controlled trials preclude at present the use of salbutamol as routine treatment for FSHD, even if we cannot exclude improvement from anabolic effects with a longer duration of treatment.     

Effects of Neurofeedback on Fibromyalgia: A Randomized Controlled Trial

BackgroundFibromyalgia is a chronic widespread pain condition that is associated with sleep disturbances and cognitive impairments. Neurofeedback has been demonstrated to improve pain, sleep quality, and fatigue. However, few studies have examined the effect of neurofeedback for patients with fibromyalgia.AimTo determine the effects of neurofeedback on pain intensity, symptom severity, sleep quality, and cognitive function in patients with fibromyalgia.DesignThis study was a randomized controlled trial.MethodEighty participants were randomized to a neurofeedback group (N = 60), receiving sensorimotor and alpha rhythm feedback for 8 weeks, or a telephone support group (N = 20).ResultsResults from the generalized estimating equation modelling revealed significant group-by-time interactions for Brief Pain Inventory pain severity (B = −1.35, SE = 0.46, p = .003) and pain interference (B = −1.75, SE = 0.41, p < .001), Revised Fibromyalgia Impact Questionnaire total scores (B = −16.41, SE = 3.76, p < .001), sleep onset latency (B = −25.33, SE = 9.02, p = .005), and Psychomotor Vigilance Test error (B = −1.38, SE = 0.55, p = .013) after adjustments for age, sex, duration of illness, and group differences at baseline.ConclusionsAn 8-week neurofeedback training regimen of sensorimotor rhythm and alpha brain waves significantly improved pain severity and interference, fibromyalgia symptom severity, sleep latency, and sustained attention in patients with fibromyalgia.     

Laser-assisted Anesthesia Prior to Intravenous Cannulation in Volunteers: A Randomized, Controlled Trial

Background: Intravenous cannulation is common and painful. Absorption of topical anesthetics is limited by the stratum corneum, the outermost layer of the epidermis. A single pulse of an erbium:yttrium–aluminum–garnet (Er:YAG) laser irradiation can remove an area of the stratum corneum, leading to enhanced uptake of topical agents, such as lidocaine, while leaving the rest of the epidermis intact. Objective: The authors hypothesized that pretreatment of the skin with laser‐assisted anesthesia would reduce the pain of venous cannulation. Methods: This was a blinded, randomized, controlled clinical trial. Subjects were 30 healthy adult volunteers. Standardized venous cannulation was performed on the dorsum of both of each subject's hands. In the study hand, the area over the target vein was pretreated with a lightweight, portable Er:YAG unit, with a fluence of 3.5 J/cm², a pulse width of 600 microseconds, and a spot diameter of 6 mm. Lidocaine 4% cream was applied to the area. After 5 minutes, the cream was wiped off and a nurse inserted an intravenous (IV) catheter and verified placement. In the control hand, a sham laser was used. Pain of laser application and pain of IV cannulation were recorded on a validated 100‐mm visual analog scale (VAS) marked “most pain” at the high end. The presence of burns, infection, and scarring at one week and at three months after the study was also noted. The levels of pain of cannulation were compared using a paired t‐test. Results: Mean subject age was 32 years; 43% were female. The mean pain of cannulation after laser‐assisted lidocaine application (13 mm, 95% CI = 8 to 19) was significantly less than after application of sham laser (29 mm, 95% CI = 22 to 36; mean difference, 15 mm, 95% CI = 6 to 24). No subject had persistent erythema or scarring. Conclusions: Pretreatment of the skin with a laser device followed by a 5‐minute topical lidocaine application reduces the pain of IV cannulation in volunteers.     

云南白药胶囊减少经尿道前列腺电切术中出血的随机双盲对照试验

目的评价云南白药胶囊在减少经尿道前列腺电切术(TURP)术中出血的疗效与安全性。方法采用随机、双盲、对照的试验方法,将40例接受TURP手术的患者随机分为试验组和安慰剂组。试验组(n=20)术前3天起口服云南白药胶囊,每次0·25g/粒,2粒,一日4次。对照组(n=20)术前3天起口服空白淀粉胶囊。术中监测冲洗液的出血总量、腺体出血指数、出血强度,比较两组住院时间、尿管保留时间及术后膀胱冲洗的时间。结果试验组在TURP出血总量、腺体出血指数及出血强度明显低于对照组,其差异有统计学意义(P<0·05);但平均住院时间、术后保留尿管时间和术后膀胱冲洗时间与对照组比较,其差异均无统计学意义(P>0·05)。用药期间,两组均无明显毒副反应发生。结论云南白药胶囊能减少TURP术中出血量,且无明显副作用,是一种安全有效的术后止血方法。     

Expiratory Muscle Training in Spinal Cord Injury: A Randomized Controlled Trial

Roth EJ, Stenson KW, Powley S, Oken J, Primack S, Nussbaum SB, Berkowitz M. Expiratory muscle training in spinal cord injury: a randomized controlled trial.

Objective

To assess the effectiveness of expiratory muscle training on the pulmonary function of spinal cord injured patients.

Design

Randomized controlled trial.

Setting

Acute inpatient rehabilitation hospital.

Participants

Patients (N=29, 22 men and 7 women) with recent traumatic, motor complete, spinal cord injury (SCI) at or above level T1 consecutively admitted to an SCI rehabilitation service. Subjects were randomized to either resistance training (n=16) or sham training (n=13).

Interventions

The subjects completed either sham training or expiratory muscle resistive training with maximal expiratory force using a small handheld device, which is a tube with an aperture at the distal end, for 10 repetitions twice a day 5 days a week for a total of 6 weeks.

Main Outcome Measures

Pulmonary function tests were measured before and after the training program and included forced vital capacity (FVC); forced expiratory volume in 1 second (FEV1); maximum expiratory pressure (MEP), which is often referred to as forced expiratory pressure; maximum inspiratory pressure (MIP), which is often referred to as negative inspiratory force; inspiratory capacity (IC); expiratory reserve volume (ERV); total lung capacity (TLC); functional residual capacity (FRC); and residual volume (RV).

Results

FVC, FEV1, and ERV improved in both groups. Although exit values of MEP were improved in both groups compared with entry values, this increase was statistically significant only in the resistance training group. No significant improvements occurred in IC, TLC, FRC, or RV from entry to exit. MIP improved in both groups, but this increase was statistically significant only in the resistance training group. There was also a significant between-group difference in MEP exit values (98cmH₂O for the resistance training group and 59cmH₂O for the sham training group, t=3.45, P=.002). Multivariate analyses failed to reveal significant effects of treatment for any of the pulmonary function tests.

Conclusions

The resistance training group had significantly greater exit MEP values than the sham training group in univariate analysis only. However, improvements in pulmonary function were noted in both the resistance training and sham training groups. Although multivariate analysis failed to reveal a significant difference between groups, these findings offer some indication that expiratory training may benefit people with SCI.     

Self-Management to Improve Function After Amputation: A Randomized Controlled Trial of the VETPALS Intervention

ObjectiveTo (1) evaluate the effects of a group-based self-management treatment intervention (VETPALS) on physical and psychosocial functioning (primary outcomes) and quality of life (secondary outcome) in individuals with amputation and (2) examine the feasibility and acceptability of the intervention in a large national health care system.DesignRandomized controlled trial with masked outcome assessment.SettingFive Veterans Affairs medical centers geographically dispersed across the United States.Participants147 individuals with amputation during the past 2 years due to chronic limb threatening ischemia (N=147).InterventionsParticipants were randomized into VETPALS (N =71) or education control (N=76). VETPALS consisted of a 4-hour workshop and 4 additional 2-hour sessions addressing self-management skills, health and activity, managing emotions, communication and social support, and maintaining goals and gains. Education control consisted of the provision of amputation-related educational materials and provider follow-up if requested.Main Outcome MeasuresPrimary outcomes were physical functioning (Short Musculoskeletal Functional Assessment) and psychosocial functioning (Patient Health Questionnaire-9). Secondary outcomes were quality of life (global) and quality of life (satisfaction with health) from the World Health Organization Quality of Life Scale (brief). Assessment was conducted at baseline, 6 weeks (treatment completion), and 6 months (follow-up).ResultsParticipants randomized to VETPALS reported significantly improved psychosocial functioning and quality of life (satisfaction with health) relative to controls at 6 months (B=1.84; 95% confidence interval, 0.37,3.31 and B=?0.61; 95% confidence interval, ?1.11,-0.12, respectively). There were no differences in physical functioning over time between VETPALS and education control at either time point. Follow-up multiple imputation sensitivity analyses produced an identical pattern of results. Among VETPALS participants, treatment initiation was low (56%), but treatment retention (93% attended 4 of 5 classes) and overall satisfaction (100% reported very helpful or better and would recommend to a friend) were high.ConclusionsGroup-based self-management improves psychosocial functioning for individuals with amputation due to chronic limb threatening ischemia. In-person participation is challenging for this population, but individuals who successfully initiate treatment typically persist and are highly satisfied.     

Written Pain Neuroscience Education in Fibromyalgia: A Multicenter Randomized Controlled Trial

Mounting evidence supports the use of face‐to‐face pain neuroscience education for the treatment of chronic pain patients. This study aimed at examining whether written education about pain neuroscience improves illness perceptions, catastrophizing, and health status in patients with fibromyalgia. A double‐blind, multicenter randomized controlled clinical trial with 6‐month follow‐up was conducted. Patients with FM (n = 114) that consented to participate were randomly allocated to receive either written pain neuroscience education or written relaxation training. Written pain neuroscience education comprised of a booklet with pain neuroscience education plus a telephone call to clarify any difficulties; the relaxation group received a booklet with relaxation education and a telephone call. The revised illness perception questionnaire, Pain Catastrophizing Scale, and fibromyalgia impact questionnaire were used as outcome measures. Both patients and assessors were blinded. Repeated‐measures analyses with last observation carried forward principle were performed. Cohen's d effect sizes (ES) were calculated for all within‐group changes and between‐group differences. The results reveal that written pain neuroscience education does not change the impact of FM on daily life, catastrophizing, or perceived symptoms of patients with FM. Compared with written relaxation training, written pain neuroscience education improved beliefs in a chronic timeline of FM (P = 0.03; ES = 0.50), but it does not impact upon other domains of illness perceptions. Compared with written relaxation training, written pain neuroscience education slightly improved illness perceptions of patients with FM, but it did not impart clinically meaningful effects on pain, catastrophizing, or the impact of FM on daily life. Face‐to‐face sessions of pain neuroscience education are required to change inappropriate cognitions and perceived health in patients with FM.     

Management of Benign Paroxysmal Positional Vertigo: A Randomized Controlled Trial

Background

Benign paroxysmal positional vertigo (BPPV) is a common presenting problem.

Objective

Our aim was to compare the efficacy of vestibular rehabilitation (maneuver) vs. conventional therapy (medications) in patients presenting to the emergency department (ED) with BPPV.

Methods

This was a prospective, single-blinded physician, randomized pilot study comparing two groups of patients who presented to the ED with a diagnosis of BPPV at a Level 1 trauma center with an annual census of approximately 75,000. The first group received standard medications and the second group received a canalith repositioning maneuver. The Dizziness Handicap Inventory was used to measure symptom resolution.

Results

Twenty-six patients were randomized; 11 to the standard treatment arm and 15 to the interventional arm. Mean age ± standard deviation of subjects randomized to receive maneuver and medication were 59 ± 12.6 years and 64 ± 11.2 years, respectively. There was no significant difference in mean ages between the two treatment arms (p = 0.310). Two hours after treatment, the symptoms between the groups showed no difference in measures of nausea (p = 0.548) or dizziness (p = 0.659). Both groups reported a high level of satisfaction, measured on a 0−10 scale. Satisfaction in subjects randomized to receive maneuver and medication was 9 ± 1.5 and 9 ± 1.0, respectively; there was no significant difference in satisfaction between the two arms (p = 0.889). Length of stay during the ED visit did not differ between the treatment groups (p = 0.873). None of the patients returned to an ED for similar symptoms.

Conclusions

This pilot study shows promise, and would suggest that there is no difference in symptomatic resolution, ED length of stay, or patient satisfaction between standard medical care and canalith repositioning maneuver. Physicians should consider the canalith repositioning maneuver as a treatment option.     

Thirst Relief Effect of 0.75% Citric Acid Spray During the Anesthesia Recovery Period: A Randomized Controlled Trial

PurposePostoperative thirst is a common clinical issue. The discomfort caused by thirst during the perioperative period is strong and significant. Postoperative thirst is associated with emotional changes, giving rise to a series of adverse psychological and physical problems to patients. This study aimed to explore the effect of 0.75% citric acid spray on thirst relief during the anesthesia recovery period in China.DesignA randomized controlled trial was conducted on subjects immediately after the removal of the endotracheal tube in a postanesthesia care unit.MethodsA total of 112 patients with TI scores ≥3 on 0–10 numeric rating scale were randomized to the intervention group (0.75% citric acid spray group; n = 56) or control group (cool water spray; n = 56) by computerized randomization. Thirst assessment was performed before and 5 minutes after the intervention. Five minutes after the intervention, if the TI score was still ≥3 points, the spray would be added and the thirst assessment would be performed again until the TI score was <3 points. The onset time, duration time, and the number of additional sprays within 20 minutes was recorded.FindingsFive minutes after the intervention, the thirst intensity score of the 0.75% citric acid spray group decreased from 5.57 ± 1.35 to 3.09 ± 1.20. The onset and duration times were 0.77 ± 0.47 min and 4.41 ± 2.59 min, respectively, and the number of spray additions in 20 min was 1.09 ± 0.92. The thirst intensity score of the cool water spray group decreased from 5.29 ± 1.52 to 3.73 ± 1.54. The onset and duration time were 0.84 ± 0.42 min and 2.77 ± 1.80 min, respectively, and the number of spray additions was 1.91 ± 1.24. No incidence of adverse events, including choking, aspiration, and allergies occurred.ConclusionFor thirsty patients during the anesthesia recovery period, the spray method is safe and has fewer side effects, including choking, aspiration, and allergies. Thus, 0.75% citric acid spray and cool water spray are both safe and effective; however, the 0.75% citric acid spray has a better thirst relief effect that lasts longer than the cool water spray.     

Internet-Based Cognitive-Behavioral Therapy for Complicated Grief: A Randomized Controlled Trial

The present study investigates the efficacy of an Internet-based cognitive-behavioral therapy program for bereaved people suffering complicated grief. The program combines established methods of psychotherapy with new technology– therapists and patients communicated exclusively by e-mail. Bereaved individuals diagnosed with complicated grief (n = 55) were randomly assigned to either the treatment group or a waiting list control condition. The 5-week intervention consisted of three modules: (1) exposure to bereavement cues; (2) cognitive reappraisal; and (3) integration and restoration. The Impact of Event Scale (IES), a failure to adapt scale, and the depression and anxiety subscales of the Brief Symptom Inventory (BSI) were used to assess treatment outcomes. Participants in the treatment group (n = 26) improved significantly relative to participants in the waiting condition on symptoms of intrusion, avoidance, maladaptive behavior, and general psychopathology, and showed a large treatment effect. Follow-up results show that this improvement was maintained after 3 months.     

天麻素注射液治疗眩晕的多中心随机单盲对照试验

目的评价天麻素注射液治疗眩晕的疗效及安全性.方法采用多中心随机单盲对照试验设计,将240例眩晕住院患者随机分为治疗组和对照组(n=120),分别予天麻素注射液600 mg和盐酸倍他司汀注射液30 mg,静滴,每日1次,疗程7 d.统计分析采用SAS统计软件,治疗前两组的基础数据比较采用非参数检验或t检验;治疗后两组临床疗效比较采用考虑中心效应的CMH方法.结果①眩晕:意向治疗(ITT)分析表明,治疗组(n=117)与对照组(n=120)疗程结束时眩晕症状临床控制率分别为71.19%和54.17%,有效率分别为90.60%和77.50%,两组间比较其差异有统计学意义(P= 0.005和P= 0.004),治疗组优于对照组.符合方案数据分析(PP)结果显示:治疗组(n=116)与对照组(n=117)疗程结束时的眩晕症状临床控制率分别为72.41%和54.70%,有效率分别为91.38%和77.78%,两组间也有统计学差异(P= 0.005和P= 0.004),治疗组优于对照组.ITT与PP分析结果一致.②前庭功能:治疗组(n=53)与对照组(n=58)疗程结束时前庭功能临床控制率分别为62.26%和42.37%,有效率分别为81.13%和76.27%,临床控制率两组间有统计学差异(P= 0.029),治疗组优于对照组,有效率两组间无统计学差异(P= 0.504),ITT与PP分析结果相同.③安全性分析结果表明:治疗组(n=120)与对照组(n=120)的不良反应发生率分别为8.33%和10.83%,两组间无统计学差异(P= 0.538).结论天麻素注射液与倍他司汀注射液均为治疗眩晕的有效药物,天麻素注射液治疗眩晕症状有效率和前庭功能下降的临床控制率优于倍他司汀注射液.昆明制药集团股份有限公司生产的天麻素注射液治疗眩晕临床疗效确切,不良反应少,患者耐受性好.